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Therapeutic Area Director, Therapeutic Area Medical
hace 3 meses
**Site Name**: GSK Tres Cantos, Madrid
**Posted Date**: Feb 7 2024
**Therapeutic Area Director, Therapeutic Area Medical Affairs Lead (Vaccines)**:
As a Director you will play a key role and will be a member of the GSK Pharma Research & Development Unit. The role reports directly into the VP Medical Director, Spain.
**_ Job purpose:_**
Responsible for all medical & scientific matters (both Clinical and Commercial-related) regarding the product/compound/disease area(s)including adequate Medical Governance and compliance with Pharmacovigilance & Risk Management requirements.
This position is a key one to the Business in medical matters, in order to ensure best business output results from scientific data generation and use. To help coping with the dual Clinical and Commercial scope of the role, the incumbent will have several medical advisors/project managers.
The role involves ensuring that Medics within the team develop as appropriate the necessary capabilities with regards to Clinical Development and Medical Affairs functions and provide coaching of direct reports.
Within GSK Spain, director will work with the relevant Business Unit (s), Market Access, Governmental Affairs and Regulatory Affairs Dept colleagues. A key function of this role will be the GSK Spain Med Dept representative in those European Teams (e.g. European Medical Networks) dealing with the compounds/products under his/her responsibility.
Jobholder will build a solid team with his/her Commercial counterparts and will devote a significant part of his/her time to European/Global (or corresponding teams) tasks.
**_ Responsibilities:_**
- Full oversight of the LOC, European and Global strategic needs of the Medical Affairs Department under his/her responsibility, directly and/or through his/her team, both from the Clinical and Commercial perspective.
- Accountable for Med Dept contribution for all programmes under his/her responsibility. Will be the Med Dept representative in European and Global Teams. This involves contributing to the strategic plans and campaigns originated in global/region and ensuring appropriate compliance with relevant internal and external procedures, regulations and codes, being responsible for the development and execution of innovative Medical affairs strategies and plans that clearly support GSK development of medicines of value for patients and customers.
- Will be ultimately responsible for the Medical Governance of the Area-related medical activities, both in terms of Development and Med Affairs, being responsible for the final signoff of the copy approval process.
- Active member of the pre-launch local business/project teams. In such role, will provide best medical input to other stakeholders (eg. Regulatory, Commercial, BD, etc.).
- Responsible, in cooperation with the Clinical Operations Director, for ensuring cross alignment in activities between the ClinOps and Medical Affairs staff including training, protocol advise and scientific engagement and the successful execution of GSK trials, according to LML role (only for Vx)
- Ensuring correct design, conduct and report of all compound-related scientific studies (e.g. epidemiological studies), as agreed with the relevant units, and approved by ISS/SCS Management, within the approved study budget: - *Contribute to global phase IIIb/IV clinical development strategy as part of brand and product planning. *May act as a Medical Responsible for specific programmes/projects, including study SAEs review to detect and to manage sentinel events properly. *Agreement (with R&D, Pharma Europe) and control of study budgets (with the assistance of the Finance Analyst in the ClinOps team) of ISS/SCS and local studies. *Support the interactions with Research Ethics Committees and AEMPS (Spanish Medicines Agency) on CTA and clinical trials issues as well as potential European Regulatory assistance (eg. when the AEMPS acts as rapporteur/co-rapporteur). *Provide support in the compilation of data from Therapy Area for submission to the Ministry of Industry’s ‘Profarma’ plan.
- Ensure constant and scientific support of his/her TA organization, to the Market Access and VEO teams including training and cross collaboration.
- Ensure liaison with patients as dictated by GSK polices in agreement with the GSK Patients Organizations.
- Accountable for the Scientific engagement activities developed in her/his responsibility area. He/She manages a team of Medical Managers, LMLs (only for Vx), Scientific Advisors / Medical Advisors, Project Managers and MSLs with a view to create a high-performance organization. Be responsible for the development needs of their teams and for stablishing and meetings resourcing needs in close liaison with Human Resources, Finance and commercial partners.
- The incumbent would be responsible for designing, planning, and leading/co-ordinating Therapy Area activities (within his/her team, with R&D and with the Commercial organization) as to ensur
